Rademikibart Add-on Treatment of an Acute COPD Exacerbation (Seabreeze STAT COPD)

Eligibility Criteria

• * Physician-diagnosed COPD with duration of ≥12 months.
• * Must have experienced at least 1 COPD exacerbation requiring the use of systemic corticosteroids (oral or parenteral) within the previous 12 months prior to Screening.
• * Participants who consent to participate in the trial while in a stable condition must have a documented historical peripheral blood eosinophil count of ≥250 cells/μL within 12 months prior to Screening Visit 1a.
• * Current or former smoker with a history of smoking of ≥10 pack-years.
• * Current acute COPD exacerbation requiring an urgent healthcare visit for treatment.
• * Peripheral blood eosinophil count of ≥300 cells/μL as part of the assessment of the index acute COPD exacerbation.
• * Requires systemic corticosteroids as standard of care treatment in the urgent healthcare setting for the current acute COPD exacerbation.
• * Regular use of immunosuppressive medication 12 weeks or 5 half-lives prior to randomization, whichever is longer.
• * Current diagnosis or a history of asthma, according to the Global Initiative for Asthma; or participants with a current diagnosis or history of Asthma COPD Overlap Syndrome.
• * Other respiratory disorders that might compromise the safety of the participant or affect the interpretation of the results.
• * Unstable ischemic heart disease, cardiomyopathy, heart failure (New York Heart Association Class III or IV), uncontrolled hypertension. Cardiac arrhythmias including paroxysmal atrial fibrillation.
• * Transient ischemic attack or stroke \<6 months from Screening Visit; hospitalization for any cardiovascular or cerebrovascular event \<6 months from Screening Visit.
• * Known or suspected history of immunosuppression.
• * History of known immunodeficiency disorder (including human immunodeficiency virus \[HIV\]-1 or HIV-2). Known medical history of hepatitis B or C.
• * History of alcohol abuse and/or drug abuse within 12 months prior to Screening.
• * History of cancer except basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success.
• * Chronic treatment with long-term oxygen therapy (LTOT) or nocturnal oxygen therapy required for \>15 hours a day.
• * Participants on long-term macrolide.
• * Current acute COPD exacerbation for which SoC was started \>48 hours prior to Screening.
• * Chest X-ray or computed tomography (CT) scan at Screening reveals evidence of clinically significant abnormalities not believed to be due to the presence of COPD, or a clinically significant pulmonary infection identified by chest X-ray (CT scan) at Screening Visit 1b.
• * Female participant who is pregnant, lactating or breast-feeding, or has a positive urinary β-hCG test prior to randomization.
• * Receipt of any marketed nonbiologic drug that modulates type 2 cytokines 30 days or 5 half-lives prior to randomization, whichever is longer.
• * Receipt of any marketed or any investigational biologic for COPD or other diseases within 16 weeks or 5 half-lives prior to randomization, whichever is longer.
• * Live, attenuated vaccinations within 4 weeks prior to randomization or planned live, attenuated vaccinations during the trial.
• * Treatment with oral corticosteroids and/or hospitalization for an exacerbation of COPD completed less than 4 weeks prior to randomization.